ChiCTR2400082037 版本V1.0 版本创建时间2024/03/19 15:33:51 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400082037 

最近更新日期：

Date of Last Refreshed on：

 2024-03-19 15:33:00 

注册时间：

Date of Registration：

 2024-03-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Empowering caregivers in the digital age: A pilot randomized controlled trial on the effects of online Meaning-Centered Psychotherapy (e-MCP) for caregivers of patients with advanced cancer

Public title：

Empowering caregivers in the digital age: A pilot randomized controlled trial on the effects of online Meaning-Centered Psychotherapy (e-MCP) for caregivers of patients with advanced cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Empowering caregivers in the digital age: A pilot randomized controlled trial on the effects of online Meaning-Centered Psychotherapy (e-MCP) for caregivers of patients with advanced cancer

Scientific title：

Empowering caregivers in the digital age: A pilot randomized controlled trial on the effects of online Meaning-Centered Psychotherapy (e-MCP) for caregivers of patients with advanced cancer

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Lam Tsz Fung 

研究负责人：

Takemura Naomi  

Applicant：

Lam Tsz Fung 

Study leader：

Takemura Naomi  

申请注册联系人电话：

Applicant telephone：

 +852 3910 2732

研究负责人电话：

Study leader's
telephone：

+852 3917 6614

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 alexltf@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 naomit@hku.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

研究负责人通讯地址：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

Applicant address：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

Study leader's address：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

University of Hong Kong

Applicant's institution：

University of Hong Kong

研究负责人所在单位：

University of Hong Kong

Affiliation of the Leader：

University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 UW 24-031

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

Name of the ethic committee：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-01-30 00:00:00

伦理委员会联系人：

Mr. Chris Yip

Contact Name of the ethic committee：

Mr. Chris Yip

伦理委员会联系地址：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China

Contact Address of the ethic committee：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2255 3923

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hkwirb@ha.org.hk

研究实施负责（组长）单位：

University of Hong Kong

Primary sponsor：

University of Hong Kong

研究实施负责（组长）单位地址：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

Primary sponsor's address：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

University of Hong Kong

具体地址：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

Institution
hospital：

University of Hong Kong

Address：

5/F, 3 Sassoon Road, Pokfulam, Hong Kong, China

经费或物资来源：

Seed Fund for Basic Research for New Staff

Source(s) of funding：

Seed Fund for Basic Research for New Staff

研究疾病：

Advanced cancer  

Target disease：

Advanced cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To evaluate the feasibility, acceptability, and preliminary effects of e-MCP on improving meaning in life (primary outcome) and secondary outcomes (distress, caregiver burden, psychological and spiritual well-being, and benefit finding) among caregivers of patients with advanced cancer, compared with enhanced usual care group.  

Objectives of Study：

To evaluate the feasibility, acceptability, and preliminary effects of e-MCP on improving meaning in life (primary outcome) and secondary outcomes (distress, caregiver burden, psychological and spiritual well-being, and benefit finding) among caregivers of patients with advanced cancer, compared with enhanced usual care group.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Aged 18 years or above 2. Current caregiver to a patient diagnosed of stage III or IV cancer 3. Able to read or understand Chinese or English 4. Score at least 4 on the Distress Thermometer (DT) with distress related to caregiving

Inclusion criteria

1. Aged 18 years or above 2. Current caregiver to a patient diagnosed of stage III or IV cancer 3. Able to read or understand Chinese or English 4. Score at least 4 on the Distress Thermometer (DT) with distress related to caregiving

排除标准：

1. Suffer from severe psychopathology or cognitive impairment

Exclusion criteria：

1. Suffer from severe psychopathology or cognitive impairment

研究实施时间：

Study execute time：

从 From 2024-03-29 00:00:00至 To 2025-09-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-01 00:00:00 至 To 2024-10-01 00:00:00

干预措施：

Interventions：

组别：

Test group

样本量：

 23

Group：

Test group

Sample size：

干预措施：

Online Meaning-Centered Psychotherapy

干预措施代码：

Intervention：

Online Meaning-Centered Psychotherapy

Intervention code：

组别：

Control group

样本量：

 23

Group：

Control group

Sample size：

干预措施：

Enhanced usual care approach

干预措施代码：

Intervention：

Enhanced usual care approach

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong Special Administrative Region 

市(区县)：

  

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

 University of Hong Kong 

单位级别：

 Tertiary 

Institution
hospital：

University of Hong Kong

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Feasibility outcomes

指标类型：

主要指标

Outcome：

Feasibility outcomes

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Psychological distress

指标类型：

次要指标

Outcome：

Psychological distress

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Meaning in life

指标类型：

次要指标

Outcome：

Meaning in life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Caregiver burden

指标类型：

次要指标

Outcome：

Caregiver burden

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Psychological well-being

指标类型：

次要指标

Outcome：

Psychological well-being

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Spiritual well-being

指标类型：

次要指标

Outcome：

Spiritual well-being

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Benefit finding

指标类型：

次要指标

Outcome：

Benefit finding

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

An independent statistician will generate the randomization list using computer and keep a secure copy of the randomization code assignments.

Randomization Procedure (please state who generates the random number sequence and by what method)：

An independent statistician will generate the randomization list using computer and keep a secure copy of the randomization code assignments.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

All outcome assessors will be blinded to subject allocation.

Blinding：

All outcome assessors will be blinded to subject allocation.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

The data will be available upon request after the study period.

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The data will be available upon request after the study period.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the University of Hong Kong Scholars Hub.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the University of Hong Kong Scholars Hub.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-03-19 15:32:59